Trial provision in clinical routine. Definition of terms and investigation of normal practice

• Published in: Chirurg 2014-01, Vol.85 (1), p.51-56
• Main Authors: Gonser, P, Matern, U
• Format: Article
• Language: ger
• Subjects: Device Approval; Equipment and Supplies; Equipment Safety; Germany; Health Promotion; Humans; Industry; Patient Safety; Physician's Role; Purchasing, Hospital; Research Personnel; Surveys and Questionnaires
• ISSN: 1433-0385
• DOI: 10.1007/s00104-013-2580-2

It has become common for hospitals to borrow medical devices from manufacturers to test and try them during the daily routine before purchasing which today is known as trial provision. This study aims at offering a precise definition of trial provisions and a description of the way of proceeding. A total of 60 medical practitioners in 5 German hospitals were surveyed (surgeons n = 40, 66.7 %, radiologists n = 12, 20 % and anesthesiologists n = 8, 13.3 %). Manufacturers and distributors of medical devices (n = 10) and hospital administration executives (n = 8) were also interviewed. Trial provisions are a promotional marketing tool for manufacturers of medical devices. By lending the device over a specific period for testing before purchasing, hospitals can gain experience in the usage and handling of devices on which a purchase decision can be made. The survey revealed that there are basically three procedural methods which can, however, differ even within one hospital. Trial provisions influence purchasing decisions in clinics. If implemented incorrectly trial provisions may compromise physical integrity, safety and health of patients and can thus lead to judicial and legal consequences for hospitals and medical staff.